Kornimate/medical-research-clean huggingface dataset:
evaluating the effect of diabetes control through intensive lifestyle modifications on diabetic peripheral neuropathy

Conditions: Diabetic Polyneuropathy; Weight Loss

Summary: the purpose of this study is to find out the impact of improving diabetes control through weight reduction and lifestyle changes on a common diabetes complication called peripheral neuropathy.


Eligibility criteria:
inclusion criteria: inclusion of intervention group: 1. men and women with established diabetes. 2. bmi between 30-45 kg/m2 3. age: 18-75 years old. 4. enrolled in the why wait program 5. diabetes duration of at least 5 years 6. hb a1c of 6.5% or higher inclusion of controls: 1. men and women with established diabetes. 2. bmi between 30-45 kg/m2 3. age: 18-75 years old. 4. diabetes duration of at least 5 years 5. hb a1c of 6.5% or higher exclusion criteria: 1. anatomic changes that preclude the measurement of the nerve conduction: foot deformities, open skin injuries/ulcers, amputations and placement of surgical plates and screws in the ankle and lower leg (tibial) area. 2. severe diabetic peripheral neuropathy as defined clinically. 3. severe peripheral vascular disease e.g absent dorsalis pedis pulsation. 4. recent weight loss/gain (10 pounds) during the past six months. 5. neuropathy due to other causes other than diabetes: alcohol abuse, liver/renal disease, toxic exposure, inflammatory disease, nutritional and vitamin deficiencies. 6. individuals with cardiac pacemakers. 7. women who are pregnant or who think they might be pregnant.
use of low dose pioglitazone to treat autosomal dominant polycystic kidney disease

Conditions: Polycystic Kidney Disease

Summary: funding source - fda oopd pioglitazone is currently used in clinical practice to treat diabetes and this study will examine the potential use of a low dose of the same drug for the treatment of polycystic kidney disease. the purpose of this study is to determine whether the diabetes drug pioglitazone (actos) is a safe and effective treatment of autosomal dominant polycystic kidney disease when treated in its early stages. pioglitazone is approved by the fda for the treatment of diabetes. pre-clinical models of polycystic kidney disease have shown that low dose treatment with pioglitazone decreases the growth of the cysts. the studies also suggest that effective pioglitazone dosing for polycystic kidney disease may be lower than that used to treat diabetes. the purpose of this study is to see if pioglitazone might slow cyst disease in humans.

patients will be randomize to placebo or 15 mg pioglitazone for 12 months, and then be crossed over to the other arm. patients will undergo mri of the liver and kidney and mrspectroscopy of the lumbar spine (if they choose as this is ancillary study) three times during the study. assessments will be every 3 months and include blood work, blood pressure, and body water assessments.

Eligibility criteria:
inclusion criteria: * male or female patients with autosomal dominant polycystic kidney disease (adpkd) aged 18-55 * estimate glomerular filtration rate (gfr) at or above ≥ 50 ml/min/1.73 m2 by any gfr formula * normal liver enzymes (alt/ast) * fasting blood glucose between 70 and120 * for female patients, a willingness to use double contraception to avoid pregnancy while in study * able to give informed consent * in the opinion of the investigator, high likelihood of progressive kidney disease exclusion criteria: * diabetes, defined as any of the following: fasting blood sugar \> 130 times two, hgba1c \> 7, on any blood sugar lowering medication, or past diagnosis of diabetes not occurring during pregnancy * uncontrolled hypertension as determined by the examining physician * history of impaired systolic function (ejection fraction \< 50%) by previous echocardiogram or known ischemic cardiovascular disease * findings suggestive of a kidney disease other than adpkd * systemic illness requiring immunosuppressive or anti-inflammatory agents * congenital absence of a kidney or history of a total nephrectomy * history of cyst reduction or partial nephrectomy * history of renal cyst aspiration within the previous year * history of bladder cancer, or gross hematuria * inability to undergo mri due to implantable devices or foreign objects that preclude mri * active renal transplant * allergy or sensitivity to any of the components of the test materials * institutionalized * currently pregnant or plans to become pregnant during the study
a trial of nnc0109-0012, an anti-il-20 biologic, in patients with active rheumatoid arthritis who are inadequate responders to anti-tnfa biologics

Conditions: Inflammation; Rheumatoid Arthritis

Summary: this trial is conducted in europe, north america and south america. the aim of this trial is to investigate the clinical efficacy of nnc0109-0012, a human monoclonal antibody, compared to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to patients with active rheumatoid arthritis (ra) who are inadequate responders to anti-tnfa biologics and are on a stable background of methotrexate (mtx) therapy.


Eligibility criteria:
inclusion criteria: * informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. * a documented diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010 * active ra, characterised by: a. above 5 tender and above 5 swollen joints based on a 28 joint count b. crp (c-reactive protein) above or equal to 1.0 mg/dl (10 mg/l) * patients must be anti-tnf (anti-tumour necrosis factor) inadequate responders to at least one but not more than two anti-tnf biologics with active disease documented in medical records at the time of discontinuation exclusion criteria: * patients with arthritis due to other autoimmune diseases than ra * any active or ongoing bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis) * history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy * patients with active malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit * females of childbearing potential who are pregnant or breast feeding or intend to become pregnant * any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
efficacy of high dose atorvastatin loading before primary percutaneous coronary intervention in st elevation myocardial infarction (statin stemi)

Conditions: Myocardial Infarction; Angioplasty; Percutaneous Coronary

Summary: although statin prior to pci has favorable effects in stable angina and acs except st elevation mi (stemi), there have been few studies for stemi. celik t et al. reported in patients with stemi that prior statin use may improve coronary blood flow after pci in patients with ami, possibly by its beneficial effects on microvascular function. but this study was retrospective, non-randomized study and evaluated the effects for chronic statin therapy not acute high dose effect. therefore, the investigators investigated whether acute high-dose statin prior to primary pci in st segment elevation myocardial infarction can have beneficial effect or not for periprocedural period and 30 days-cardiac events.


Eligibility criteria:
inclusion criteria: 1. the patient must be at least 18 years and 80 years of age. 2. the patient had the symptoms of acute myocardial infarction within 12 hours with st segment elevation of more than 1 mm in at least two contiguous leads of ekg or new onset lbbb. 3. the patient or guardian agrees to the study protocol and provides informed, written consent. exclusion criteria: 1. patients to whom pci can not be undergone within 12 hours from receiving the study drug 2. cardiogenic shock or symptomatic hypotension or sitting sbp \< 95 mmhg 3. the history of major surgery, trauma, retinal hemorrhage, significant gastrointestinal or genitourinary bleeding within recent 6 weeks; history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit 4. history of cerebrovascular attack within two years, or cerebrovascular attack with a significant residual neurological deficit 5. severe or malignant hypertension (= sitting sbp \> 180 mmhg and/or sitting dbp \> 105 mmhg) 6. the history or diagnosis of vasculitis; renal insufficiency (the level of serum creatinine is two times higher than the upper limit of normal of each center) 7. the patients who might die of other disease than cardiac disease during the trial.

Keywords: myocardial infarction coronary angioplasty myocardial infarction, angioplasty, transluminal, percutaneous coronary
indomethacin germinal matrix hemorrhage/intraventricular hemorrhage (gmh/ivh) prevention trial

Conditions: Intraventricular Hemorrhage (IVH); Bleeding in the Brain; Prematurity; Very Low Birth Weight Infants

Summary: the purpose of this multicenter trial is to determine if indomethacin prevents bleeding in the brain of very low birth weight preterm infants.

intraventricular hemorrhage (ivh) or bleeding in the brain remains a major problem of preterm infants. this randomized, placebo-controlled multicenter trial enrolled 505 infants of 600 to 1250g birth weight to determine if indomethacin lowers the incidence of ivh, and 125 term infant controls. during this longitudinal trial, follow-up assessments have been performed at the ages of 3, 4 1/2, 6, 8, 12 and 16 years. the initial results at age 3 years revealed no advantages to the indomethacin group over and above the decreases in ivh, however, the results did show a significant increase in ventriculomegaly in the "placebo" group. results at 4 1/2, 6 and 8 years of age showed beneficial effects of indomethacin on cognitive and behavioral outcomes over and above the effects on preventing ivh but not at later ages. at 12 and 16 years, no significant influence of indomethacin on cognitive outcome was noted. age, gender and zip-code matched control subjects were added when the preterm subjects were 8 years. throughout all subsequent testing, term controls have higher iq and peabody picture vocabulary scores. additional longitudinal volumetric, functional and diffusion tensor mr imaging studies showed differences between preterm and term control subjects at 8, 12 and 16 years of age. these were consistent with utilization of the right hemisphere and left cerebellum for language in the preterm group compared to term controls. no effects of indomethacin were seen. the study closed on 31 march 2012.

Eligibility criteria:
* preterm infants \< 1250 g birth weight * admitted to participating institution \< 6 hrs of age * no evidence for congenital malformations * cranial us at 6 postnatal hours without evidence of grades iii - iv intraventricular hemorrhage

Keywords: intraventricular hemorrhage (ivh) bleeding in the brain indomethacin prematurity very low birth weight infants
transcranial direct current stimulation and cognitive behavioural programme on post-stroke fatigue

Conditions: Stroke

Summary: this study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.

this study will adopt a randomized controlled trial. participants will be randomized into one of the 3 groups. one group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. one group will receive home-based physical training only.

Eligibility criteria:
inclusion criteria: * diagnosed with stroke at least 6 months ago * fatigue assessment scale score ≥20 * cognitively intact exclusion criteria: * unstable medical conditions leading to fatigue * under any clinical trials * with any other neurological diseases * history of transient ischemic attack * contraindications to tdcs
gemcitabine plus flavopiridol in treating patients with advanced solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: phase i trial to study the effectiveness of gemcitabine plus flavopiridol in treating patients who have advanced solid tumors. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells.

objectives: i. determine the maximum tolerated dose of gemcitabine and flavopiridol in patients with advanced solid tumors. ii. determine the toxicity and safety profile of this regimen in these patients. iii. determine the pharmacokinetic profile of this regimen in this patient population. outline: this is a dose-escalation study. patients receive gemcitabine iv over 1-2.5 hours on days 1 and 8 and flavopiridol iv continuously over 24 hours on days 2 and 9. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of gemcitabine and flavopiridol until the maximum tolerated dose (mtd) is reached. the mtd is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. projected accrual: approximately 6-58 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists * previously untreated disease allowed * no large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis) * no cns metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 2,000/mm3 * platelet count at least 100,000/mm3 * no prior thrombotic events hepatic: * bilirubin no greater than 1.5 mg/dl * sgot no greater than 2 times upper limit of normal renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no clinically significant cardiac disease * no prior deep venous thrombus * no prior arterial vascular event * no prior myocardial infarction * no unstable angina * no prior transient ischemic attack or cerebrovascular accident * no cardiac arrhythmias that could be related to cardiac ischemia pulmonary: * no clinically significant pulmonary disease * no history of pulmonary embolism other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no active infection * no severe malnutrition or intractable emesis * no chronic diarrheal disease within the past 6 months prior concurrent therapy: chemotherapy: * no more than 1 prior chemotherapy regimen * at least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * prior gemcitabine or flavopiridol allowed * no other concurrent chemotherapy radiotherapy: * at least 3 weeks since prior radiotherapy and recovered * no prior radiotherapy to more than 50% of bone marrow * no concurrent radiotherapy

Keywords: unspecified adult solid tumor, protocol specific
the impact of transcutaneous spinal cord stimulation (tscs) and gait training on walking function in patients with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: aim 1: determine the neurophysiologic impact of transcutaneous spinal cord stimulation (tscs) within a single session. the investigators hypothesize that subjects will demonstrate increased volitional muscle activity and strength with tscs. this will be assessed by surface emg and hand-held dynamometry of the dominant-side quadriceps muscle during maximum volitional contraction (mvc) and measurement of gait speed. subjects will be tested in both tscs and sham conditions. aim 2: determine the impact of tscs and gait training on walking function. the investigators hypothesize that concurrent tscs and gait training will augment walking function in subjects with isci, as compared to gait training alone. subjects will participate in an eight-week program of gait training with tscs and be assessed with clinically relevant outcome measures, to include the timed up and go, 10-meter walk test, walking index for spinal cord injury ii, and 6-minute walk test.


Eligibility criteria:
inclusion criteria: * 18-65 years old * \>1 year post sci * non-progressive sci * neurological level above t10 * tolerates upright position for \>30 minutes * medically stable (no hospitalizations in last 3 months) * able to comply with procedures and follow up * are legally able to make their own health care decisions exclusion criteria: * progressive sci/d (ms, als, adem, etc.) * open wounds at stimulation site * pregnant women * rom limitations impacting gait training * cardiac pacemaker/defibrillator * active cancer diagnosis * currently receiving tscs * evidence of uncontrolled autonomic dysreflexia * non-english speaking subjects will not be targeted
efficacy and safety of oral versus intravenous ibuprofen for pda treatment in elbw infants

Conditions: Patent Ductus Arteriosus

Summary: to determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.

to determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.seventy elbw preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. one of the following echocardiographic criteria of a duct size \>1.5 mm, a left atrium-to-aorta ratio \>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.

Eligibility criteria:
inclusion criteria: * birth weight below 1000 gram * diagnosed patent ductus arteriosis by echocardiographic examination exclusion criteria: * accompanied other congenital cardiac anomalies * severe thrombocytopenia \< 60.000 * severe intracranial bleeding (grade 3-4) * intestinal abnormality and necrotising enterocolitis

Keywords: patent ductus arteriosis i̇buprofen extremely low birth weigh infant
a study of the safety and efficacy of subcutaneously administered regn475 in patients with osteoarthritis of the knee

Conditions: Osteoarthritis

Summary: this is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo). each patient will receive one sc injection of regn475 or placebo and 1 iv infusion of either regn475 or placebo, on day 1 (baseline) in order to preserve the blind, patients receiving regn475 sc will also receive placebo iv, and patients receiving regn475 iv will also receive placebo sc.


Eligibility criteria:
inclusion criteria: 1. diagnosis of oa of the knee according to american college of rheumatology (acr) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit. 2. kellgren-lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to screening. exclusion criteria: 1. significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study. 2. patients with joint replacement in the affected knee. 3. intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit. 4. women who are pregnant or breast-feeding.
a registry on the faraview technology of the opal hdx mapping system when used with the farawave nav ablation catheter in the treatment of atrial fibrillation

Conditions: Atrial Fibrillation; Pulsed Field Ablation; FARAPULSE

Summary: the study is designed to collect data on the acute and long-term (1 year) safety and effectiveness outcome when an ablation procedure is performed in a commercial and standard of care setting with the farapulse™ pulsed field ablation system, whereby the farawave nav ablation catheter is used in conjunction with the opal hdx mapping system. in addition, the study intends to analyse the association between several workflow-related variables, inclusive of intracardiac electro-anatomical mapping and ablation strategy with procedure-related complications (safety parameters), and one-year effectiveness parameters.


Eligibility criteria:
inclusion criteria: * subjects are prospectively planned and intended to be treated with the farapulse™ pulsed field ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care * subjects who are willing and capable of providing informed consent * subjects who are willing and capable of participating to this registry at an approved clinical investigational center * subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law * subjects are planned to undergo an ablation procedure whereby the farawave nav pf ablation catheter is used in conjunction with the opal hdx mapping system. exclusion criteria: * subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study. exceptions are when the subject is participating in a mandatory governmental registry, or a purely observational registry, that do not interfere with the current study